Cleared Traditional

MACH-SIGMA HANDPIECE, ULTRAPUSH

K980162 · Nsk Nakanishi, Inc. · Dental
Jun 1998
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K980162 is an FDA 510(k) clearance for the MACH-SIGMA HANDPIECE, ULTRAPUSH, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on June 5, 1998, 140 days after receiving the submission on January 16, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K980162 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1998
Decision Date June 05, 1998
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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